QA Project Manager (m/f/d)

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

• Lead and support global RnD project team, and represent QA globally in RnD sub-teams, as well as at global quality board meetings and project development gate meetings
• Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise
• Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables
• Ensure that the strategy followed within the assigned projects is in line with RnD QA strategies and goals and in compliance to cGMP guidelines and internal procedures
• Understand and proactively manage the interactions of project related activities between RnD QA and other departments inside or outside of RnD
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the RnD project leader and/or to any other relevant project team member(s)
• Provide input to contracts and QA agreements with third parties. Approve project-specific QA agreement amendments for assigned projects
• Lead or participate in global and/or cross-functional initiatives

• Bachelor
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Product/Medical Devices (combination products) manufacturing and control
• Experience with Health Authority Inspections (FDA and EMA in particular), Notified Body inspections and knowledge of RegCMC requirements for NB, Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs)
• Broad experience in combination product development as well as in Quality Assurance and/or Quality Control departments
• Experience in Technical Operations or equivalent experience from external company is preferred
• Proven track record in successfully supporting interdisciplinary teams, e.g. scientists working on technical or methodological projects, in RnD or equivalent experience from external company or other line function
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills
• Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes
• Fluent English required (oral & written). Good skills in site (local) language desired (oral)

• Leadership role
• International work environment

Ihr Kontakt

Referenznummer
892961/1

Kontakt aufnehmen
Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch

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